Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Mucinous Ductal Breast Carcinoma, Papillary Ductal Breast Carcinoma, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Tubular Ductal Breast Carcinoma
Conditions
Brief summary
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
Detailed description
PRIMARY OBJECTIVES: I. Freedom from local failure and freedom from regional failure. SECONDARY OBJECTIVES: I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy. III. To correlate toxicity, cosmesis, and local control with molecular markers. OUTLINE: Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.
Interventions
RADIATIONExternal beam radiation therapy
Hypofractionated accelerated radiation therapy over 11 days
Sponsors
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed * American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3, T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (T4d) is allowed * Patients with locally advanced breast cancer on clinical exam and diagnostics ( \> 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed * Multifocal/multicentric disease is allowed * Negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin * Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician * Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above * Chest wall reconstruction is allowed * The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy * Signed study-specific informed consent form prior to study entry * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* Patient with distant metastases (M1) * Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma * Patient with T1N0 or T2N0 disease * Prior radiation therapy to the chest * Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * Patients with co-existing medical conditions with life expectancy \< 2 years * Patients with psychiatric (with the possible exception of incompetence as defined by New Jersey \[NJ\] law) or addictive disorders that would preclude obtaining informed consent * Other malignancy, except non-melanomatous skin cancer, \< 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous * Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females * Women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local, Regional, and/or Distant Failure | Up to 5 years after dose of last treatment, an average of 62 months | Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Grade Three or Higher Toxicities | weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years. | Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years. |
| Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications | Up to five years after dose of last treatment, an average of 62 months | — |
Countries
United States
Participant flow
Recruitment details
Patients enrolled at the Rutgers Cancer Institute of New Jersey and at the Huntsman Cancer Institute at the University of Utah. After enrolling 69 patients with stage II-III breast cancer, 67 women were eligible for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Radiation Therapy Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days | 67 |
| Total | 67 |
Baseline characteristics
| Characteristic | Radiation Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Region of Enrollment United States | 67 participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 67 |
| other Total, other adverse events | 67 / 67 |
| serious Total, serious adverse events | 1 / 67 |
Outcome results
Primary
Number of Participants With Local, Regional, and/or Distant Failure
Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.
Time frame: Up to 5 years after dose of last treatment, an average of 62 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiation Therapy | Number of Participants With Local, Regional, and/or Distant Failure | 12 Participants |
Secondary
Count of Participants With Grade Three or Higher Toxicities
Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
Time frame: weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation Therapy | Count of Participants With Grade Three or Higher Toxicities | 7 participants |
Secondary
Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications
Time frame: Up to five years after dose of last treatment, an average of 62 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiation Therapy | Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications | 15 Participants |